ketorolac tromethamine; phenylephrine hydrochloride · Rayner Surgical · NDA 205388
Omidria
Earliest generic entry, as listed
23 Apr 2034
Blocked by patent: US 9066856 (pediatric extension), US 9486406 (pediatric extension).
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9066856 | drug product | 23 Apr 2034 |
| US 9066856 listing row | drug product | 23 Oct 2033 |
| US 9066856 listing row | pediatric extension · sets the listed date | 23 Apr 2034 |
| US 9486406 | drug product | 23 Apr 2034 |
| US 9486406 listing row | drug product | 23 Oct 2033 |
| US 9486406 listing row | pediatric extension · sets the listed date | 23 Apr 2034 |
| US 9855246 | drug product | 23 Oct 2033 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205388 · 001 · RLD | solution, irrigation | EQ 0.3% BASE;EQ 1% BASE | 23 Apr 2034 |